NCT07832162

Brief Summary

This randomized controlled trial will compare vacuum-assisted closure (VAC) therapy with conventional wound dressings for the treatment of open contaminated and dirty wounds. The study will be conducted in the Department of General Surgery, Jinnah Postgraduate Medical Centre (JPMC), Karachi. Eligible patients aged 15 to 60 years with open contaminated or dirty wounds measuring 5-10 cm and classified as American Society of Anesthesiologists (ASA) grade I or II will be randomly allocated to either VAC therapy or conventional dressings. The primary outcome will be mean duration of wound healing, measured in days from initiation of the assigned treatment until complete wound healing according to predefined clinical criteria. The study will compare the duration of wound healing between the two treatment groups.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress18%
Sep 2026Dec 2026

First Submitted

Initial submission to the registry

September 11, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

September 20, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2026

Last Updated

September 21, 2026

Status Verified

September 1, 2026

Enrollment Period

3 months

First QC Date

September 11, 2026

Last Update Submit

September 16, 2026

Conditions

Keywords

VAC THERAPYNEGATIVE PRESSURE WOUND THERAPYCONVENTIONAL WOUND DRESSINGWOUND HEALINGSURGICAL WOUNDSWOUND CAREVacuum-Assisted Closure

Outcome Measures

Primary Outcomes (1)

  • Duration of Wound Healing

    Duration of wound healing, measured in days from initiation of the assigned treatment until complete wound healing according to the predefined clinical criteria. The mean duration in days will be compared between the VAC therapy and conventional dressing groups.

    From initiation of treatment until complete wound healing, up to 2 weeks.

Secondary Outcomes (3)

  • Wound Infection

    From initiation of treatment until completion of the 2-week follow-up period.

  • Length of Hospital Stay

    During the index hospital admission.

  • Need for Additional Surgical Intervention

    From initiation of treatment until completion of the 2-week follow-up period.

Study Arms (2)

VAC Therapy

EXPERIMENTAL

Participants will receive vacuum-assisted closure (VAC) therapy for wound management.

Device: Vacuum-Assisted Closure (VAC) Therapy Description:

Conventional Dressing

ACTIVE COMPARATOR

Participants will receive conventional saline-soaked wound dressings.

Other: Conventional Wound Dressing

Interventions

The wound will be covered with polyurethane foam and a multi-hole drain will be placed over it. The dressing will be sealed with an airtight dressing and connected to a negative-pressure system providing intermittent negative pressure of 125 mmHg, with 45 minutes ON and 15 minutes OFF cycles. VAC dressing changes will be performed every 48-72 hours.

VAC Therapy

Saline-soaked dressing will be placed over the wound and bandage applied, with dressing changes every 24 hours

Conventional Dressing

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients having open contaminated and dirty wounds of size 5 - 10cm as per operational definition.
  • Patients between ages 15 to 60 years.
  • Both gender
  • ASA grade I \& II
  • Willing to provide written informed consent.

You may not qualify if:

  • Patients with wounds having dry eschar, malignancy in wound, untreated osteomyelitis, exposed blood vessels and organs, long term anticoagulant therapy, bleeding disorders and fistula to organ / body cavities. Dermatological disorders like acute dermatitis, fungal infections of perianal region.
  • All the patients presented with exposed bone, tendons or nerve will be excluded from study
  • Pregnant women.
  • Patients on medications, such as corticosteroids, immunosuppressive agents or chemotherapy. All above will be assessed on history and documented medical history.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jinnah Postgraduate Medical Centre

Karachi, Sindh, 74600, Pakistan

Location

Related Publications (2)

  • Jamali MA, Memon SA, Sameena N, Tahmida A. Vacuum assisted closure versus conventional dressings in treatment of open untidy wounds. Esculapio. 2016;12(3):139-144.

    RESULT
  • Cheema SA, Hafsa N, Shumaila RD, Urwa TA. Comparison of vacuum assisted closure technique versus conventional dressing for management of wounds in term of duration of wound healing. Ann Pak Med Coll. 2020;14(1):1-4.

    RESULT

MeSH Terms

Conditions

Surgical Wound

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

DrainageTherapeuticsSurgical Procedures, OperativeWound Closure Techniques

Central Study Contacts

Dr Aourangzaib Dr Aourangzaib, MBBS, FCPS

CONTACT

Dr Irfan Dr Irfan, mbbs

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly allocated by lottery method to one of two parallel treatment groups. Group A will receive vacuum-assisted closure (VAC) therapy, while Group B will receive conventional wound dressings. The duration of wound healing will be compared between the two groups.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asisstant professor

Study Record Dates

First Submitted

September 11, 2026

First Posted

September 21, 2026

Study Start

September 20, 2026

Primary Completion (Estimated)

December 9, 2026

Study Completion (Estimated)

December 9, 2026

Last Updated

September 21, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared with other researchers. The data will be collected and used solely for the purposes of this study and will be maintained confidentially in accordance with institutional and ethical requirements.

Locations